Benzoyl peroxide is one of the most popular over-the-counter acne products and is often combined with other ingredients in various acne treatments. It works by providing oxygen to the skin’s pores and killing the type of bacteria that require an oxygen-free environment to survive. Benzoyl peroxide also helps clear excess dead skin to keep pores clear, which reduces blackheads and other potential blockages. (1)
In June, 2011, the Food and Drug Administration (FDA) released guidelines specifying how manufacturers should provide safety warnings on the labeling of their products containing benzoyl peroxide. These instructions were released to further clarify what had been recommended in March of 2010 after research of the safety of benzoly peroxide use had been completed. (4)
New labeling must include:
· Benzoyl peroxide products must state that they should be used with sunscreen as well as outline new warnings (i.e., the products should not be used on broken skin or warnings about potential skin irritation)
· Benzoyl peroxide generally is recognized as safe and effective as an OTC topical acne drug product or GRASE (Generally Recognized As Safe and Effective).
· Consistency with the standardized Drug Facts formatting requirements of permitted single and combination of ingredients in benzoyl peroxide formulations.
Benzoyl peroxide was first approved by the FDA in 1985. It was originally labeled as Category I, or GRASE (Generally Recognized As Safe and Effective). In 1991, the FDA changed it to Category III, which means “more data needed”, based on the results of studies on mice that indicated benzoyl peroxide might be carcinogenic, mutogenic, and possibly photocarcinogenic. After examining the data, the FDA returned benzoly peroxide to Category I GRASE (Generally Recognized As Safe and Effective) in concentrations of 2.5 to 10%. (2)
It was during this testing period it was determined that benzoyl peroxide can decrease the skin’s tolerance to UV radiation.